SunGen Pharma Announces to Partner with Athenex Pharmaceutical to Launch Bivalirudin through PIV Challenges in US
June 27 2019 - 8:00AM
SunGen Pharma, a privately held specialty pharmaceutical company
which develops, contract manufactures, and sells pharmaceutical
finished products, today announced to launch Bivalirudin for
Injection in the near future through their joint venture Peterson
Athenex with Athenex Pharmaceuticals (Nasdaq:ATNX). This
tentatively approved US ANDA is exclusively licensed from the
current ANDA holder, Hainan Shuangcheng Pharmaceuticals.
US Market Sales of Bivalirudin for Injection were
$81.8M for the year ending December 2018 according to IQVIA
data. Bivalirudin is an anticoagulant
(thrombin inhibitor) that helps prevent the formation
of blood clots.
Dr. Isaac Liu, Co-CEO and President of SunGen
Pharma, stated, “We are proud to add Bivalirudin for Injection to
our growing portfolio of specialty injectable products, as well as
announce our third injectable product launch. We will continue to
look for opportunities to launch products to fill marketplace
needs. The launch of Bivalirudin demonstrates a strong development
to our partnership with companies around the world. We look forward
to collaborating further to bring specialty pharmaceutical drugs to
the market.”
Bivalirudin ANDA was originally submitted to the US
FDA in December 2016 and was tentatively approved in May 2018. In
May 2019, ANDA holder submitted their PIV challenge application to
US FDA and notified the RLD holder at the same time. Within 45 days
of the notice, the RLD holder has not filed any lawsuit against the
ANDA holder, which indicates success of the PIV challenge.
Bivalirudin ANDA is currently waiting for US FDA’s final
approval.
SunGen Pharma started its oral and topical research
and development center in January 2016.
In August 2016, it entered into a Development and
License Agreement with Elite Pharmaceuticals, Inc. to develop and
commercialize four generic pharmaceutical products.
SunGen formed a sales and marketing joint venture
with Athenex Pharmaceuticals in September 2016 named Peterson
Athenex Pharmaceuticals, to market seven pharmaceutical
products.
SunGen established its injectable division in
October 2017 through the acquisition of a privately held
pharmaceutical company based in Monmouth Junction, New Jersey. The
company launched its first injectable product Terbutaline Sulfate
as a prefilled liquid vial with a strength of 1mg/1ml. The product
was launched on July 10th, 2017.
In August 2018, SunGen announced it has entered
into a strategic manufacturing partnership with Grand River Aseptic
Manufacturing to collaborate in the manufacturing and
commercialization of generic injectable pharmaceutical
products.
In March 2019, SunGen launched Busulfan injection
through the acquisition of the ANDA from Sandoz.
SunGen and its partners have filed over 13 ANDAs
by the end of Q1 2019, and have received 5 approvals from US FDA.
The shortest ANDA approval time was ten months.
About SunGen Pharma LLC
SunGen Pharma, LLC is a privately held specialty
pharmaceutical company which develops, contract manufactures, and
sells pharmaceutical finished products. SunGen specializes in the
development of oral solid extended release, topical and complex
injectable products. SunGen has business partnerships with many
North American, European and Asian-based generic pharmaceutical
companies to develop, manufacture, and sell several pharmaceutical
products around the world.
Contact:SunGen Pharma
LLCOffice: (609) 606-1070www.sungenpharm.com
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